APP13007 meets endpoints in inflammation, pain treatment after cataract surgery
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Positive top-line results were reported for a phase 3 clinical study investigating APP13007 to treat inflammation and pain after cataract surgery, according to a press release from Formosa Pharmaceuticals and AimMax Therapeutics.
The randomized, double-masked CPN-302 trial, which included 370 participants randomly assigned to receive either APP13007 (clobetasol propionate 0.05%) or placebo after cataract surgery, achieved both primary endpoints of producing rapid and sustained clearance of ocular inflammation and resolving ocular pain after two daily drops for 14 days.
On postoperative day 15, 57.8% of participants who received APP13007 had an anterior chamber cell count of zero compared with 18.9% of participants who received placebo (P < .001). Additionally, 85.4% of participants who received APP13007 were free of ocular pain as early as postoperative day 4 compared with 51.4% of participants who received placebo (P < .001).
The ophthalmic nanosuspension formulation was well tolerated, with infrequent adverse events of IOP elevation that were managed without the need to stop treatment. There were no reports of drug-related serious adverse events.
“We are extremely pleased to have successfully completed the two large pivotal clinical trials over a challenging pandemic period and to have clearly demonstrated the superiority of APP13007 in both primary efficacy endpoints, paving the way for an NDA submission,” Laurene Wang, PhD, CEO of AimMax Therapeutics, said in the release.
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